AsthmaPhase 1NCT02345928
A Single Ascending Dose Study in Healthy Participants and Multiple Ascending Dose Study of CNTO 7160 in Participants With Asthma and Participants With Atopic Dermatitis
A Phase 1 study testing Part 1: CNTO 7160, Part 2 (Asthma): CNTO 7160 and Part 2 (Atopic Dermatitis): CNTO 7160 in people with Asthma and Atopic Dermatitis, run by Janssen Research & Development, LLC at 7 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of single ascending dose of CNTO 7160 administered intravenously (IV) in healthy participants and multiple dose administered IV in participants with asthma and atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Atopic Dermatitis, Healthy
- What is being tested?
- Part 1: CNTO 7160, Part 2 (Asthma): CNTO 7160 and Part 2 (Atopic Dermatitis): CNTO 7160
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 5 Aug 2014to 16 Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part 1 (Healthy Participants): Participant must have a body weight in the range of 50 to 100 kilogram (kg) inclusive and have a body mass index (BMI) of 19 to 30 kilogram per meter square (kg/m^2) inclusive
- Part 1 (Healthy Participants): Participant must be healthy on the basis of physical examination, medical history, vital signs and 12-lead ECG performed at screening
- Part 2 (Asthma Participants): Participant must have a body weight in the range of 50 to 125 kg inclusive and have a BMI of 19 to 32 kg/m^2 inclusive
- Part 2 (Asthma Participants): Participant must have a physician documented diagnosis of asthma for at least 12 months before screening
- Part 2 (Atopic Dermatitis Participants): Participant must have a body weight in the range of 50 to 100 kg inclusive and have a BMI of 19 to 30 kg/m^2 inclusive
- Part 2 (Atopic Dermatitis Participants): Participant has physician documented diagnosis of atopic dermatitis for at least 12 months before screening based on UK refinements of the Rajka and Hanifin criteria
Who cannot join
- Part 1 (Healthy Participants): Participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit
- Part 1 (Healthy Participants): Participant currently has or has a history of any clinically significant cardiovascular disease, including but not limited to a history of angina or myocardial infarction, congestive heart failure, symptomatic atherosclerotic vascular disease, or arrhythmia.
- Part 2 (Asthma Participants): Participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit
- Part 2 (Asthma Participants): Participant has or have had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received IV antibiotics for a serious infection during the 4 months prior to the Screening Visit
- Part 2 (Atopic Dermatitis Participants): Participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit.
- Part 2 (Atopic Dermatitis Participants): Participant has or have had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received IV antibiotics for a serious infection during the 4 months prior to the Screening Visit
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Germany5 sites
Study site
Berlin
Study site
Hamburg
Study site
Hanover
Study site
Kiel
Study site
Mönchengladbach
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Ascending Dose Study of CNTO 7160 in Subjects With Asthma and Subjects With Atopic Dermatitis
The purpose of this study is to evaluate the safety and tolerability of single ascending dose of CNTO 7160 administered intravenously (IV) in healthy participants and multiple dose administered IV in participants with asthma and atopic dermatitis.
Read the detailed description
This is a Phase 1, randomized, placebo-controlled, multicenter study of CNTO 7160. The study consists of Screening Period, In-patient period (6 days for healthy participants, 11 days for asthmatic participants and atopic dermatitis participants) and outpatient period (105 days for healthy participants, 110 days for asthmatic and atopic dermatitis participants). The total duration of participation for each participant will be approximately 21 weeks for healthy participants, 25 weeks for asthmatic participants, and atopic dermatitis participants. All eligible participants will be randomly assigned to receive active agent or placebo. The study will be conducted in 2 parts. In Part 1, single ascending doses of CNTO 7160 or placebo will be administered to sequential cohorts of healthy participants as an IV infusion. In Part 2, ascending multiple doses of CNTO 7160 or placebo will be administered as IV infusions to sequential cohorts of participants with asthma or atopic dermatitis. Blood samples will be collected for assessment of pharmacokinetic and pharmacodynamics parameters in both part 1 and 2 parameters, along with assessment of safety and clinical effects in part 2. Participants' safety will be monitored throughout the study.
- Conditions
- Asthma, Atopic Dermatitis, Healthy
- Being tested
- Part 1: CNTO 7160, Part 2 (Asthma): CNTO 7160, Part 2 (Atopic Dermatitis): CNTO 7160, Part 1 and Part 2: Placebo
- Keywords
- Safety, Efficacy, CNTO 7160, Healthy, Asthma, Atopic Dermatitis
- Medical subject headings
- Asthma, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 1: CNTO 7160Drug
Participants will receive Drug CNTO7160 administered IV infusion at escalating doses (with a starting dose of 0.001 mg/kg).
Part 2 (Asthma): CNTO 7160Drug
Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
Part 2 (Atopic Dermatitis): CNTO 7160Drug
Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
Part 1 and Part 2: PlaceboDrug
Participants will receive single IV infusion of placebo matched to CNTO 7160.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose 1 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 1. Receives: Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo |
| Part 1: Dose 2 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 2. Receives: Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo |
| Part 1: Dose 3 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 3. Receives: Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo |
| Part 1: Dose 4 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 4. Receives: Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo |
| Part 1: Dose 5 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 5. Receives: Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo |
| Part 1: Dose 6 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 6. Receives: Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo |
| Part 1: Dose 7 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 7. Receives: Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo |
| Part 1: Dose 8 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 8. Receives: Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo |
| Part 1: Dose 9 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 9. Receives: Drug: Part 1: CNTO 7160; Drug: Part 1 and Part 2: Placebo |
| Part 2 (Asthma): Dose 1 | Experimental | Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks). Receives: Drug: Part 2 (Asthma): CNTO 7160; Drug: Part 1 and Part 2: Placebo |
| Part 2 (Asthma): Dose 2 | Experimental | Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks). Receives: Drug: Part 2 (Asthma): CNTO 7160; Drug: Part 1 and Part 2: Placebo |
| Part 2 (Atopic Dermatitis): Dose 1 | Experimental | Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks). Receives: Drug: Part 2 (Atopic Dermatitis): CNTO 7160; Drug: Part 1 and Part 2: Placebo |
| Part 2 (Atopic Dermatitis): Dose 2 | Experimental | Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks). Receives: Drug: Part 2 (Atopic Dermatitis): CNTO 7160; Drug: Part 1 and Part 2: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 1)
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Measured: Through Week 17
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 2)
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Measured: Through Week 21
Secondary outcomes (10)
Maximum Observed Serum Concentration (Cmax) (Part 1)
Cmax (microgram per millileter [mcg/mL]) will be summarized by treatment group.
Measured: Up to Week 17 after dose
Maximum Observed Serum Concentration (Cmax) (Part 2)
Cmax (mcg/mL) after the first and last dose will be summarized by treatment group.
Measured: Up to Week 21 after dose
Area Under the Serum Time Curve [AUC(0-t) and AUC(0-infinity)] (Part 1)
AUC (mcg*day/mL) will be summarized by treatment group.
Measured: Up to Week 17 after dose
Area Under the Serum Concentration Versus Time Curve [AUC(t1-t2)] (Part 2)
AUC (mcg*day/mL) will be summarized by treatment group.
Measured: Up to Week 21 after dose
Number of Participants With Antibodies to CNTO 7160 (Part 1)
The incidence of participants with anti-CNTO 7160 antibodies will be summarized by treatment group.
Measured: Up to Week 17
Number of Participants with Antibodies to CNTO 7160 (Part 2)
The incidence of participants with anti-CNTO 7160 antibodies will be summarized by treatment group.
Measured: Up to Week 21
Change From Baseline in Immunoglobulin E (IgE) (Part 2)
Change from Baseline in immunoglobulin E (IgE) Concentration (international unit per millileter [IU/mL]) through Week 21 will be summarized by treatment group.
Measured: Baseline, Week 21
Change from Baseline in Chemokine (C-C motif) Ligand 17 (CCL17) (Part 2)
Change from Baseline in Chemokine (C-C motif) Ligand 17 (CCL17) concentration (picogram per millileter [pg/mL]) through Week 21 will be summarized by treatment group.
Measured: Baseline, Week 21
Change From Baseline in Forced Expiratory Volume in 1 second (FEV1) in Participants With Asthma
Changes in FEV1 (liter [L]) from baseline through end of follow up will be summarized by treatment group.
Measured: Baseline Up to week 21
Change From Baseline in Eczema Area Severity Index (EASI) in Participants With Atopic Dermatitis
Changes in EASI score from baseline through the end of follow up will be summarized by treatment group.
Measured: Baseline up to week 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start5 Aug 2014
- Primary completion16 Mar 2017
- Study completion16 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345928
- Sponsor's protocol ID
- CR105130
- Other IDs
- CNTO7160ASH1001, 2014-000633-23, 2014
- Status last verified
- Nov 2020
- First submitted
- 27 Aug 2014
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Publications
Nnane I, Frederick B, Yao Z, Raible D, Shu C, Badorrek P, van den Boer M, Branigan P, Duffy K, Baribaud F, Fink D, Yang TY, Xu Z. The first-in-human study of CNTO 7160, an anti-interleukin-33 receptor monoclonal antibody, in healthy subjects and patients with asthma or atopic dermatitis. Br J Clin Pharmacol. 2020 Dec;86(12):2507-2518. doi: 10.1111/bcp.14361. Epub 2020 Jun 14.
PubMed 32415720
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Ascending Dose Study of CNTO 7160 in Subjects With Asthma and Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02345928
- Acronym / sponsor ID
- CR105130
- Conditions
- Asthma, Atopic Dermatitis, Healthy
- Keywords
- Safety, Efficacy, CNTO 7160, Healthy, Asthma, Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2014 (actual)
- Primary completion
- 16 Mar 2017 (actual)
- Study completion
- 16 Mar 2017 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of single ascending dose of CNTO 7160 administered intravenously (IV) in healthy participants and multiple dose administered IV in participants with asthma and atopic dermatitis.
Detailed description
This is a Phase 1, randomized, placebo-controlled, multicenter study of CNTO 7160. The study consists of Screening Period, In-patient period (6 days for healthy participants, 11 days for asthmatic participants and atopic dermatitis participants) and outpatient period (105 days for healthy participants, 110 days for asthmatic and atopic dermatitis participants). The total duration of participation for each participant will be approximately 21 weeks for healthy participants, 25 weeks for asthmatic participants, and atopic dermatitis participants. All eligible participants will be randomly assigned to receive active agent or placebo. The study will be conducted in 2 parts. In Part 1, single ascending doses of CNTO 7160 or placebo will be administered to sequential cohorts of healthy participants as an IV infusion. In Part 2, ascending multiple doses of CNTO 7160 or placebo will be administered as IV infusions to sequential cohorts of participants with asthma or atopic dermatitis. Blood samples will be collected for assessment of pharmacokinetic and pharmacodynamics parameters in both part 1 and 2 parameters, along with assessment of safety and clinical effects in part 2. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose 1 | Experimental | Drug: Part 1: CNTO 7160, Drug: Part 1 and Part 2: PlaceboDrug CNTO7160 or Placebo administered IV infusion Dose 1. |
| Part 1: Dose 2 | Experimental | Drug: Part 1: CNTO 7160, Drug: Part 1 and Part 2: PlaceboDrug CNTO7160 or Placebo administered IV infusion Dose 2. |
| Part 1: Dose 3 | Experimental | Drug: Part 1: CNTO 7160, Drug: Part 1 and Part 2: PlaceboDrug CNTO7160 or Placebo administered IV infusion Dose 3. |
| Part 1: Dose 4 | Experimental | Drug: Part 1: CNTO 7160, Drug: Part 1 and Part 2: PlaceboDrug CNTO7160 or Placebo administered IV infusion Dose 4. |
| Part 1: Dose 5 | Experimental | Drug: Part 1: CNTO 7160, Drug: Part 1 and Part 2: PlaceboDrug CNTO7160 or Placebo administered IV infusion Dose 5. |
| Part 1: Dose 6 | Experimental | Drug: Part 1: CNTO 7160, Drug: Part 1 and Part 2: PlaceboDrug CNTO7160 or Placebo administered IV infusion Dose 6. |
| Part 1: Dose 7 | Experimental | Drug: Part 1: CNTO 7160, Drug: Part 1 and Part 2: PlaceboDrug CNTO7160 or Placebo administered IV infusion Dose 7. |
| Part 1: Dose 8 | Experimental | Drug: Part 1: CNTO 7160, Drug: Part 1 and Part 2: PlaceboDrug CNTO7160 or Placebo administered IV infusion Dose 8. |
| Part 1: Dose 9 | Experimental | Drug: Part 1: CNTO 7160, Drug: Part 1 and Part 2: PlaceboDrug CNTO7160 or Placebo administered IV infusion Dose 9. |
| Part 2 (Asthma): Dose 1 | Experimental | Drug: Part 2 (Asthma): CNTO 7160, Drug: Part 1 and Part 2: PlaceboDrug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks). |
| Part 2 (Asthma): Dose 2 | Experimental | Drug: Part 2 (Asthma): CNTO 7160, Drug: Part 1 and Part 2: PlaceboDrug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks). |
| Part 2 (Atopic Dermatitis): Dose 1 | Experimental | Drug: Part 2 (Atopic Dermatitis): CNTO 7160, Drug: Part 1 and Part 2: PlaceboDrug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks). |
| Part 2 (Atopic Dermatitis): Dose 2 | Experimental | Drug: Part 2 (Atopic Dermatitis): CNTO 7160, Drug: Part 1 and Part 2: PlaceboDrug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Part 1 (Healthy Participants): Participant must have a body weight in the range of 50 to 100 kilogram (kg) inclusive and have a body mass index (BMI) of 19 to 30 kilogram per meter square (kg/m^2) inclusive
- Part 1 (Healthy Participants): Participant must be healthy on the basis of physical examination, medical history, vital signs and 12-lead ECG performed at screening
- Part 2 (Asthma Participants): Participant must have a body weight in the range of 50 to 125 kg inclusive and have a BMI of 19 to 32 kg/m^2 inclusive
- Part 2 (Asthma Participants): Participant must have a physician documented diagnosis of asthma for at least 12 months before screening
- Part 2 (Atopic Dermatitis Participants): Participant must have a body weight in the range of 50 to 100 kg inclusive and have a BMI of 19 to 30 kg/m^2 inclusive
Key exclusion criteria (6 listed)
- Part 1 (Healthy Participants): Participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit
- Part 1 (Healthy Participants): Participant currently has or has a history of any clinically significant cardiovascular disease, including but not limited to a history of angina or myocardial infarction, congestive heart failure, symptomatic atherosclerotic vascular disease, or arrhythmia.
- Part 2 (Asthma Participants): Participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit
- Part 2 (Asthma Participants): Participant has or have had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received IV antibiotics for a serious infection during the 4 months prior to the Screening Visit
- Part 2 (Atopic Dermatitis Participants): Participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part 1: CNTO 7160Participants will receive Drug CNTO7160 administered IV infusion at escalating doses (with a starting dose of 0.001 mg/kg). | Drug | Part 1: Dose 1, Part 1: Dose 2, Part 1: Dose 3, Part 1: Dose 4, Part 1: Dose 5, Part 1: Dose 6, Part 1: Dose 7, Part 1: Dose 8, Part 1: Dose 9 |
| Part 2 (Asthma): CNTO 7160Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks). | Drug | Part 2 (Asthma): Dose 1, Part 2 (Asthma): Dose 2 |
| Part 2 (Atopic Dermatitis): CNTO 7160Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks). | Drug | Part 2 (Atopic Dermatitis): Dose 1, Part 2 (Atopic Dermatitis): Dose 2 |
| Part 1 and Part 2: PlaceboParticipants will receive single IV infusion of placebo matched to CNTO 7160. | Drug | Part 1: Dose 1, Part 1: Dose 2, Part 1: Dose 3, Part 1: Dose 4, Part 1: Dose 5, Part 1: Dose 6, Part 1: Dose 7, Part 1: Dose 8, Part 1: Dose 9, Part 2 (Asthma): Dose 1, Part 2 (Asthma): Dose 2, Part 2 (Atopic Dermatitis): Dose 1, Part 2 (Atopic Dermatitis): Dose 2 |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 1)
Time frame: Through Week 17
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 2)
Time frame: Through Week 21
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
10 secondary outcomes
Maximum Observed Serum Concentration (Cmax) (Part 1)
Time frame: Up to Week 17 after dose
Maximum Observed Serum Concentration (Cmax) (Part 2)
Time frame: Up to Week 21 after dose
Area Under the Serum Time Curve [AUC(0-t) and AUC(0-infinity)] (Part 1)
Time frame: Up to Week 17 after dose
Area Under the Serum Concentration Versus Time Curve [AUC(t1-t2)] (Part 2)
Time frame: Up to Week 21 after dose
Number of Participants With Antibodies to CNTO 7160 (Part 1)
Time frame: Up to Week 17
Number of Participants with Antibodies to CNTO 7160 (Part 2)
Time frame: Up to Week 21
Change From Baseline in Immunoglobulin E (IgE) (Part 2)
Time frame: Baseline, Week 21
Change from Baseline in Chemokine (C-C motif) Ligand 17 (CCL17) (Part 2)
Time frame: Baseline, Week 21
Change From Baseline in Forced Expiratory Volume in 1 second (FEV1) in Participants With Asthma
Time frame: Baseline Up to week 21
Change From Baseline in Eczema Area Severity Index (EASI) in Participants With Atopic Dermatitis
Time frame: Baseline up to week 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Results publication: PubMed 32415720Nnane I, Frederick B, Yao Z, Raible D, Shu C, Badorrek P, van den Boer M, Branigan P, Duffy K, Baribaud F, Fink D, Yang TY, Xu Z. The first-in-human study of CNTO 7160, an anti-interleukin-33 receptor monoclonal antibody, in healthy subjects and patients with asthma or atopic dermatitis. Br J Clin Pharmacol. 2020 Dec;86(12):2507-2518. doi: 10.1111/bcp.14361. Epub 2020 Jun 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Part 1: CNTO 7160, Part 2 (Asthma): CNTO 7160 and Part 2 (Atopic Dermatitis): CNTO 7160 in people with Asthma and Atopic Dermatitis, run by Janssen Research & Development, LLC at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 1) (time frame: Through Week 17). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02345928, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.